Granulocyte Colony-Stimulating Factor (“G-CSF”): Patient profiles, Scheduling Patterns and Clinical Outcomes

Study identification

• EU PAS number:
  EUPAS38906
• Study ID:
  45192
• Official title and acronym:
  Granulocyte Colony-Stimulating Factor (“G-CSF”): Patient profiles, Scheduling Patterns and Clinical Outcomes
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is a retrospective cohort study assessing patient characteristics, scheduling patterns and clinical outcomes among patients with a diagnosis of breast cancer, colorectal cancer, non-Hodgkin’s lymphoma (NHL), non-small cell lung cancer (NSCLC), or ovarian cancer, treated with pegfilgrastim in the US Oncology network (USON) between January 1, 2018 and October 31, 2019, with follow-up until December 31, 2019. This study proposes to describe real-world patient profiles, treatment patterns and clinical outcomes with use of the different G-CSF products in USON clinics. All study data will originate from the electronic healthcare record (EHR) of the USON. There are 2 phases in this study. The objective of the Phase 1 analysis will be to describe treatment scheduling patterns with pegfilgrastim among the study population. The objective of Phase 2 will be to describe clinical outcomes and resource utilization by conducting a chart review.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 400 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual:02/06/2020

Study start date

Planned:31/10/2020

Actual:31/10/2020

Data analysis start date

Planned:15/01/2021

Actual:15/01/2021

Date of final study report

Planned:31/12/2021

Actual:14/01/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable